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Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease (BUCCONAFLD)

Primary Purpose

Non-Alcoholic Fatty Liver Disease

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
saliva samples
medical questionnaire
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Non-Alcoholic Fatty Liver Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: subjects with NAFLD confirmed by a biopsy less than 1 year old subjects over the age of 18 subjects able to receive information on the course of the study and to understand the information form to participate in the study the subjects who gave their non-objection to participate in the study Exclusion Criteria: Having another associated cause of liver disease or steatosis such as viral infections and autoimmune disease With alcohol consumption >30g/d (men) or 20g/d (women) With a history of cirrhosis decompensation Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion With chronic or acute gastrointestinal disease With a history of gastrointestinal surgery modifying the anatomy During pregnancy or breastfeeding With a history of oral surgery in the month prior to inclusion For whom oral surgery is planned between the collection of the non-objection and the inclusion in the odontology service At risk of infection (existence of one or more known chronic infectious pathologies) and/or chronic renal failure (creatinine clearance < 60ml/min). Suffering from a general pathology contraindicating the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the French National Agency for the Safety of Medicines and Health Products ANSM) Under legal protection, dependent, under guardianship or curatorship

Sites / Locations

  • CHU ToulouseRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

F1-F2 NAFLD

F3-F4 NAFLD

Arm Description

Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old

Patients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old

Outcomes

Primary Outcome Measures

frequency of Porphyromonas gingivalis in the saliva
compare the mean frequency of Porphyromonas gingivalis in the saliva of people with stage F1-F2 NAFLD versus people with stage F3-F4.

Secondary Outcome Measures

Full Information

First Posted
December 8, 2022
Last Updated
December 8, 2022
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT05654129
Brief Title
Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease
Acronym
BUCCONAFLD
Official Title
Non-interventional Study Exploring the Relationship Between Porphyromonas Gingivalis and the Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease (NAFLD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 5, 2022 (Actual)
Primary Completion Date
December 5, 2022 (Actual)
Study Completion Date
December 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Many studies suggest that Porphyromonas gingivalis, a virulent periodontopathogenic bacterium, is associated with many systemic diseases such as cardiovascular diseases. In addition, a recent study showed the impact of Porphyromonas gingivalis on Non-Alcoholic Steatosis Liver Disease (NASH). It would be responsible for aggravation of non-alcoholic fatty liver disease (NAFLD) by stimulating inflammation in the damaged liver tissue.
Detailed Description
Non-alcoholic fatty liver disease is becoming the leading cause of chronic liver disease with a prevalence of 20% worldwide. The prognosis depends on the degree of fibrosis: patients with a low degree of fibrosis (F0-F2) have a good prognosis unlike those with severe fibrosis or cirrhosis (F3-F4), exposed to excess mortality from cardiovascular diseases , cancers, and complications of cirrhosis. The diagnosis of the fibrosis stage is histological but the worsening of the fibrosis remains unknown. The intestinal microbiota is an etiological factor in NAFLD and dysbiosis is associated with the severity of fibrosis. There is also a physiopathological rationale between oral bacterial microbiota and NAFLD. The oral microbiota is very rich, it corresponds to a reservoir of 1010 bacteria of Gram-negative bacteria (BGN). Its dysbiosis causes oral infections like periodontal diseases, immuno-infectious pathologies linked to an imbalance between the bacterial etiological factor and the host's immune defenses. Many studies suggest that Porphyromonas gingivalis, a virulent periodontopathogenic bacterium, is associated with many systemic diseases such as cardiovascular diseases. In addition, a recent study showed the impact of Porphyromonas gingivalis on Non-Alcoholic Steatosis Liver Disease (NASH). It would be responsible for aggravation of non-alcoholic fatty liver disease (NAFLD) by stimulating inflammation in the damaged liver tissue. the hypothesis that the salivary levels of Porphyromonas Gingivalis could be associated with the degree of severity of fibrosis in NAFLD patients, and would constitute a new therapeutic target for the evaluation of fibrosis. This work would open new perspectives in treatment strategies.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Alcoholic Fatty Liver Disease

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
people with stage F1-F2 NAFLD versus people with stage F3-F4
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
182 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
F1-F2 NAFLD
Arm Type
Other
Arm Description
Patients with NAFLD stage 1 or 2 confirmed by a biopsy less than 1 year old
Arm Title
F3-F4 NAFLD
Arm Type
Other
Arm Description
Patients with NAFLD stage 3 or 4 confirmed by a biopsy less than 1 year old
Intervention Type
Other
Intervention Name(s)
saliva samples
Intervention Description
saliva samples (non-invasive, in the sites evaluated during the partial survey) will be perform by one of the investigators .
Intervention Type
Other
Intervention Name(s)
medical questionnaire
Intervention Description
a complete medical questionnaire will be carried out (general, lifestyle and quality of life) will be perform by one of the investigators .
Primary Outcome Measure Information:
Title
frequency of Porphyromonas gingivalis in the saliva
Description
compare the mean frequency of Porphyromonas gingivalis in the saliva of people with stage F1-F2 NAFLD versus people with stage F3-F4.
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subjects with NAFLD confirmed by a biopsy less than 1 year old subjects over the age of 18 subjects able to receive information on the course of the study and to understand the information form to participate in the study the subjects who gave their non-objection to participate in the study Exclusion Criteria: Having another associated cause of liver disease or steatosis such as viral infections and autoimmune disease With alcohol consumption >30g/d (men) or 20g/d (women) With a history of cirrhosis decompensation Having taken antibiotics, prebiotics or probiotics in the month prior to inclusion With chronic or acute gastrointestinal disease With a history of gastrointestinal surgery modifying the anatomy During pregnancy or breastfeeding With a history of oral surgery in the month prior to inclusion For whom oral surgery is planned between the collection of the non-objection and the inclusion in the odontology service At risk of infection (existence of one or more known chronic infectious pathologies) and/or chronic renal failure (creatinine clearance < 60ml/min). Suffering from a general pathology contraindicating the performance of diagnostic procedures such as periodontal probing (patients at high risk of infective endocarditis according to the French National Agency for the Safety of Medicines and Health Products ANSM) Under legal protection, dependent, under guardianship or curatorship
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent BLASCO-BAQUE
Phone
0675188124
Ext
+33
Email
blasco-baque.v@chu-toulouse.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Cathy Nabet
Ext
+33
Email
catherine.nabet@univ-tlse3.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent BLASCO-BAQUE
Organizational Affiliation
University Hospital, Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Toulouse
City
Toulouse
ZIP/Postal Code
31059
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent BLASCO-BAQUE
Phone
0675188124
Ext
+33
Email
blasco-baque.v@chu-toulouse.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Porphyromonas Gingivalis and Severity of Fibrosis in Patients With Non-alcoholic Fatty Liver Disease

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